A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
Iressa will be taken orally once daily without interruption. Docetaxel will be administered
intravenously once weekly for two out of every three weeks. Patients will also receive
dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help
prevent an allergic reaction.
Every week that chemotherapy is given, blood tests and vital signs will be taken.
After the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done
to assess the progress of the disease. If the cancer is responding to the treatment and no
unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.
CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks
thereafter to monitor the progress of the disease.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy
Matthew Kulke, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|